Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 544
- 试验地点
- 1
- 主要终点
- Occurrence of ischaemia of the hand
研究概览
简要总结
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.
详细描述
This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.
The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.
Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Stage 5 chronic kidney disease, on dialysis or not on dialysis;
- •Requiring the creation of an arteriovenous fistula;
- •Membership of a social insurance scheme;
- •Patient having been informed and having formulated his/her oral non-opposition to participate in the research.
排除标准
- •Contraindication to the proposed surgery ;
- •Reduced life expectancy in the opinion of the investigator;
- •Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
- •Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
- •Other surgical or medical intervention planned during the study;
- •Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- •Participating in another clinical trial, or in a period of exclusion from another clinical trial;
- •Patient under guardianship or deprived of liberty.
结局指标
主要结局
Occurrence of ischaemia of the hand
时间窗: 12 months
Number and proportion of patients with ischaemia (Yes = stages 1, 2 or 3/No = stage 0) according to the preoperative American Vascular Surgery ischaemia classification : 0 - nothing 1. \- cold hand 2. \- pain on exercise and/or during dialysis 3. \- permanent pain, wound (ulceration, necrosis, gangrene)
次要结局
未报告次要终点